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Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category: Professional
All Job Posting Locations: Raritan, New Jersey, United States of America, Washington, District of Columbia, United States of America
Job Description: About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, Regulatory Policy Research. This position is a hybrid role and can be located in Washington D.C. or Raritan, NJ.
The Senior Manager, Regulatory Policy Research sits within the Policy Research and Operations (PRO) group, which will be responsible for shaping and scaling the tools, research approaches, regulatory intelligence resources, and operational processes that enable the Global Regulatory Policy and Intelligence (GRPI) team to anticipate policy developments, prioritize issues, and execute high-impact regulatory policy strategies.
This role leads complex cross-functional work across GRPI and the broader GRA organization. This individual will perform analysis of emerging regulatory and scientific issues to identify actionable insights; develop, roll-out, and manage fit-for-purpose systems and processes that improve policy planning, commenting, advocacy, and external engagement.
The Senior Manager is expected to operate with independence and minimal supervision, provide strategic recommendations to policy leaders, and work capably across the organization’s scientific, policy, operational, and technology domains.
Principal Responsibilities:
Strategic Research and Regulatory Intelligence Leadership
• Lead complex scientific, regulatory, and policy research to inform GRPI priorities, advocacy positions, strategic plans, and leadership decision-making.
• Translate emerging policy, regulatory, and scientific developments into clear implications, options, and recommendations for GRPI and GRA leaders.
• Establish research standards, improve intelligence processes, and mentor others on effective use of regulatory intelligence tools and sources.
Regulatory Intelligence Strategy and Capability Building
• Shape regulatory intelligence approaches that help GRPI anticipate external developments, identify risks and opportunities, and support timely, evidence-based policy decisions.
• Lead training, adoption, and best-practice sharing for regulatory intelligence resources across GRPI and relevant GRA stakeholders.
Research Synthesis and Executive Deliverables
• Develop high-quality documents, presentations, policy positions, and leadership materials that synthesize complex information into practical implications and recommend actions aligned with business, scientific, and regulatory priorities.
Policy Tools, Systems, and Process Strategy
• Design, develop, and scale tools, processes, and technology-enabled approaches that strengthen GRPI priority-setting, policy planning, commenting, knowledge management, and performance tracking.
• Identify unmet business needs, define user requirements, recommend solutions, and drive implementation and adoption across GRPI and GRA.
• Partner with the PRO Director on strategic direction while independently leading execution of complex, high-visibility initiatives.
Commenting Program Leadership
• Lead operational strategy and governance for GRPI-led commenting efforts on health authority documents and global regulatory initiatives.
• Ensure commenting processes are efficient, compliant, well-documented, and aligned with Johnson & Johnson policy positions.
• Facilitate cross-functional alignment, identify areas of policy sensitivity or inconsistency, support resolution of competing viewpoints, and ensure final outputs reflect clear, evidence-based company positions.
Knowledge Management and Digital Enablement
• Lead development and continuous improvement of the GRPI website and related collaboration tools to ensure they provide effective support for policy planning, research, commenting activities, and knowledge sharing.
Policy Strategy and External Engagement Enablement
• Partner with policy leads to shape and operationalize policy strategies for priority external engagements, including trade associations, consortia, workshops, and other policy forums.
• Provide strategic coordination across policy topics, identify cross-cutting themes, anticipate decision points, and ensure stakeholders have the insights, materials, and follow-up needed to advance Johnosn & Johnson objectives.
Consultant and Resource Strategy
• Partner with the PRO Director to plan and manage external consultant support for GRPI priorities, including scopes of work, renewals, work allocation, deliverable quality, budget tracking, and vendor performance.
• Identify when external expertise is needed and ensure consultant resources are aligned to the highest-priority policy and intelligence needs.
People Leadership
• In a non-supervisory capacity, provide day-to-day leadership, coaching, prioritization, and performance feedback for team members to support policy research, intelligence, operations, tools, and commenting activities.
• Set expectations, reviews work quality, supports capability develop
Qualifications:
• A minimum of a Bachelor’s degree in a scientific discipline (public health administration, regulatory affairs, public policy or related) is required. Advanced degree (Master’s, PharmD, Ph.D.) in a scientific discipline is preferred.
• A minimum of 8 years in the pharmaceutical, biotechnology, medical device, public health, regulatory agency, or trade association environment is required.
• A minimum of 6 years of experience in Regulatory Affairs, regulatory policy, regulatory intelligence, public health policy or a related function is required.
• Solid understanding of the global regulatory environment, including U.S., European Union (EU), and Asia Pacific (AP) regions is preferred.
• Experience at a health authority, trade association, or policy-focused organization is preferred.
• Advanced project management skills, including experience leading complex cross-functional initiatives and projects in a global matrix environment, required.
• Experience working with stakeholders with varied areas of expertise is required.
• Demonstrated ability to translate regulatory, scientific, or policy information into strategic recommendations for senior stakeholders is required.
• Experience leading regulatory policy, intelligence, commenting, knowledge management, or external engagement initiatives is preferred.
• Experience providing work direction, coaching, feedback, and prioritization for direct reports, matrixed colleagues, or project team members is preferred.
• Familiarity with regulatory intelligence platforms and collaboration tools (e.g., Citeline, Cortellis, SharePoint, Power BI, Microsoft Teams) is required.
• Experience with technology-enabled process improvement, digital health, artificial intelligence, or emerging regulatory policy topics is preferred.
• Must have excellent oral and written communication and facilitation skills.
• Must have strong analytical skills.
• Must have strong negotiation and stakeholder management skills.
• The ability to translate complex scientific, regulatory, and policy information into clear insights, recommendations, and executive-ready deliverables is required.
• This position will require minimal travel.
#LI-Hybrid
Required Skills:
Preferred Skills: Advocacy Communications, Budget Management, Business Storytelling, Corporate Communications Strategy, Corporate Management, Developing Others, Government Relations, Inclusive Leadership, Knowledge Networks, Leadership, Managing Managers, Negotiation, Public Affairs, Regulatory Development, Relationship Building, Representing, Stakeholder Engagement, Strategic Thinking
The anticipated base pay range for this position is : $137,000.00 - $235,750.00
Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits